Variable-stiffness imaging  window and production method thereof

ABSTRACT

An imaging window of an imaging catheter includes a first imaging window section and a second imaging window section. The first imaging window section has a finite length and is formed from a first material having a flexural modulus. The second imaging window section has a finite length and is formed from a second material having a flexural modulus. The flexural modulus of the first material is different than the flexural modulus of the second material.

PRIORITY CLAIM

The present application claims the benefit of copending U.S. ProvisionalPatent Application Ser. No. 61/484,941, filed May 11, 2011, whichapplication is incorporated herein by reference in its entirety.

BACKGROUND

The present invention generally relates to catheters. The presentinvention further relates to catheters having sheaths with variablestiffness. The present invention still further relates to intravascularimaging catheters.

Percutaneous coronary interventions in patients suffering from coronaryartery disease often involve deployment of a stent in order to keep opena coronary artery that supplies oxygenated blood to a patient's heart.An intravascular ultrasound imaging catheter may be used to assessadequacy of stent deployment, including the extent of stent appositionand determination of the minimum luminal diameter within the stent.

Current intravascular ultrasound imaging catheters having a mechanicallyrotating imaging core include an imaging window having a single flexuralmodulus. An imaging window having a single flexural modulus avoidsmeasurement inaccuracies due to image artifacts that may be introducedby use of an imaging window having a variable flexural modulus, such asbraided sleeves or extrusions of varying wall thickness. The flexuralmodulus, or stiffness, of the imaging window affects catheterpushability and catheter trackability. Pushability describes how a forcetransmitted longitudinally at the catheter proximal end is transferredto longitudinal movement of the catheter distal end. Trackabilitydescribes how easily the catheter is able to reach its destination(e.g., a coronary artery segment). The use of an imaging window with asingle flexural modulus presents a trade-off between catheterpushability and trackability. Current intravascular ultrasound imagingcatheters exhibit limitations in navigating some coronary arteries.

Safe and effective delivery of an intravascular ultrasound imagingcatheter to a coronary artery requires an imaging window havingsufficient pushability to reach the coronary artery and adequatetrackability to navigate the tortuous coronary arteries. It would beadvantageous if the stiffness of the imaging window could be varied withlength in order to optimize the balance between catheter pushability andtrackability. It would be further advantageous if the imaging windowprovides uniform imaging performance along its entire length.

SUMMARY

In one embodiment, an imaging window of an imaging catheter includes afirst imaging window section, the first imaging window section having afinite length and being formed from a first material having a flexuralmodulus and a second imaging window section. The second imaging windowsection has a finite length and is formed from a second material havinga flexural modulus. The flexural modulus of the first material isdifferent than the flexural modulus of the second material.

The catheter has a proximal end and a distal end. The first imagingwindow section is proximal to the second imaging window section and theflexural modulus of the first material is greater than the flexuralmodulus of the second material.

The first and second materials are substantially transparent toultrasound energy. The first and second materials are polyethylenematerials. The first and second materials each have imaging performancecharacteristics that are substantially equivalent.

In another embodiment, an imaging catheter has an imaging windowincluding a plurality of serially aligned imaging window sections, eachimaging window section having a finite length and being formed from amaterial having a flexural modulus. The flexural modulus of the materialforming each imaging window section is different from the flexuralmodulus of the material forming each of the other imaging windowsections.

In another embodiment, a method of making an imaging window for use inan imaging catheter includes the steps of providing a mandrel having aanti-stick coating thereon, successively loading a plurality of imagingwindow tubing sections onto the mandrel, wherein each of the tubingsections has a flexural modulus and a flexural modulus different fromthe flexural modulus of the other tubing sections, joining the tubingsections end-to-end together to form an imaging window section, andremoving the imaging window section from the mandrel.

The successively loading step may be performed by loading the imagingwindow tubing sections onto the mandrel in a given order correspondingto progressive change in the flexural modulus of the imaging windowsections. The given order corresponds to a progressive increase in theflexural modulus of the imaging window tubing sections. The imagingwindow tubing sections are formed from polyethylene material.

The joining step may include applying heat to the imaging window tubingsections. The joining step may further include covering the imagingwindow tubing sections with a heat shrink tubing prior to applying heatto the imaging window tubing sections. The joining step may furtherinclude using a vertical laminator.

The plurality of imaging window tubing sections may form a firstplurality of imaging window tubing sections to form a first imagingwindow section, and the method may further include successively loadinga second plurality of imaging window tubing sections onto the mandrel,wherein each of the tubing sections of the second plurality of imagingwindow tubing sections has a flexural modulus and a flexural modulusdifferent from the flexural modulus of the other tubing sections of thesecond plurality of imaging window tubing sections, placing a spacertubing between the first and second pluralities of imaging window tubingsections, joining the tubing sections end-to-end together of the firstand second pluralities of imaging window tubing sections to form firstand second imaging window sections, respectively, and removing the firstand second imaging window sections from the mandrel.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention, together with further features and advantages thereof,may best be understood by making reference to the following descriptionstaken in conjunction with the accompanying drawings, in the severalfigures of which like reference numerals identify identical elements,and wherein:

FIG. 1 is a partial sectional side view of a prior art catheter;

FIG. 2 is a partial sectional side view of another prior art catheter;

FIG. 3 is a partial sectional side view of a catheter embodying theinvention;

FIG. 4 is a partial sectional side view of a catheter embodying theinvention;

FIG. 5 is a flow diagram illustrating processing steps for manufacturingan imaging window embodying the invention;

FIG. 6 is a partial sectional side view of one embodiment of an imagingwindow assembly fixture; and

FIG. 7 is a partial sectional side view of another embodiment of animaging window assembly fixture.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIG. 1 shows a partial sectional side view of a prior art catheter 100having a stiffness that varies with length. The catheter includes aproximal sheath 110 and a distal section 120. The distal section 120includes a braided sleeve 130 wherein the braided sleeve has acontinually reduced pitch and weave density in a direction from theproximal section 110 toward the catheter distal tip (not shown). Thebraided sleeve filaments 132,134,136,138 may be relatively hardmaterials, including metals or nylon. The braided sleeve providesincreasing flexibility on progressing distally (i.e., to the right inFIG. 1). The progressive flexibility of the distal section 120 may beadvantageous for catheter pushability and trackability, but the braidedsleeve 130 is problematic for intravascular ultrasound imaging. Thebraided sleeve filaments 132,134,136,138 may cause undesirablescattering of the ultrasonic field and imaging artifacts.

FIG. 2 shows a sectional side view of another prior art catheter 200having a stiffness that varies with length. The catheter includes aproximal sheath 210 and a distal sheath 222. The wall thickness of thedistal sheath 222 decreases with length and provides increasingflexibility on progressing distally (i.e., to the right in FIG. 2). Theprogressive flexibility of the distal sheath 222 may be advantageous forcatheter pushability and trackability, but the varying wall thickness isproblematic for intravascular ultrasound imaging. The varying wallthickness may lead to incorrect registration of vessel wall and stentposition in ultrasound images and impact accuracy of lumen diameter andarea measurements.

Referring now to FIG. 3, a sectional side view of a monorail catheter300 according to one embodiment of the present invention is shown. Thecatheter 300 includes a midshaft sheath 310, an imaging window 320, anda distal tip 340. The midshaft sheath 310 may be composed ofhigh-density polyethylene (HDPE). The midshaft sheath 310 providesadequate pushability for the catheter and may have a flexural modulus inthe range 200 kilopound per square inch (ksi) to 250 ksi, generally 225ksi. The midshaft sheath 310 may be bonded to the imaging window 320 bymeans of thermal bonding, for example. The imaging window 320 mayfurther be bonded to the distal tip 340. The distal tip 340 may take theform as described for example in additional detail in Published UnitedStates Patent Application, US2010/0057019, Published Mar. 4, 2010, thecomplete disclosure of which is hereby incorporated herein by reference.As an exemplary embodiment only and without limiting the invention, thefollowing description will be directed to deployment in an intravascularultrasound imaging catheter that is suitable for imaging of coronaryarteries. Similarly, with no intention to limit the invention, thefollowing description will be further directed at the case wherein theimaging window 320 includes three sections.

The outer diameter of the imaging window 320 may be constant andsufficiently small for the catheter to be delivered through a 6 F guidecatheter. Further, the inner diameter of the imaging window 320 may beconstant in the rage 0.024″ to 0.038″, generally 0.0335″. The imagingwindow wall thickness may be in the range 0.001″ to 0.007″, generally0.005″.

Polyethylene (PE) has been found to be a suitable material for animaging window. Further, polyethylene is available in different flexuralmoduli, or stiffnesses. High-density polyethylene has a larger stiffnessthan low-density polyethylene (LDPE). Polyethylene sheaths ofintermediate stiffness can be composed of medium density PE (MDPE) whichcan be formed from blends of HDPE and LDPE.

The three sections of the imaging window 320 include an imaging windowproximal section 324, an imaging window middle section 328, and animaging window distal section 332. The distal end of the imaging windowproximal section 324 is bonded to the proximal end of the imaging windowmiddle section 328. The distal end of the imaging window middle section328 is bonded to the proximal end of the imaging window distal section332. The length of the imaging window 320 may be in the range 100 mm to200 mm, generally 100 mm to 150 mm. The length of the imaging windowgenerally depends on the length of the vessel to be imaged. Thestiffness of the imaging window 320 decreases proximally to distally.The imaging window proximal section 324 may be composed of HDPE and hasa flexural modulus in the range 195 ksi to 245 ksi, generally 220 ksi.The length of the imaging window proximal section 324 may be in therange 40 mm to 100 mm, generally 70 mm. The imaging window middlesection 328 is composed of MDPE and has a flexural modulus in the range155 ksi to 205 ksi, generally 180 ksi. The length of the imaging windowmiddle section 328 may be in the range 30 mm to 70 mm, generally 50 mm.The imaging window distal section 332 is composed of LDPE and has aflexural modulus in the range 35 ksi to 85 ksi, generally 60 ksi. Thelength of the imaging window distal section 332 may be in the range 10mm to 50 mm, generally 20 mm.

Referring now to FIG. 4, the catheter 300 may more specifically includean imaging core 340 that further includes a flexible drive cable 342, atransducer housing 344, an ultrasonic transducer stack 346, and atransmission line 348. The variations in ultrasonic properties of theimaging window sections 324, 328, 332, including the speed of sound,acoustic impedance, and attenuation, are sufficiently low such thatvariation in imaging performance through the different imaging windowsections is negligible. Further, the ultrasonic attenuation of theimaging window sections is sufficiently low such that the imaging windowsections are substantially transparent to ultrasound energy.

One embodiment of a method for producing a variable stiffness imagingwindow according to the present invention includes loading onto apolytetrafluoroethylene (PTFE) coated mandrel in sequence imaging windowproximal tubing, imaging window middle tubing, and imaging window distaltubing. The imaging window tubing sections may be bonded by means of avertical laminator heater. The production method of the imaging windowof the present invention is not particularly limited. The followingmethod represents one embodiment of the production method.

A flow diagram illustrating processing steps for manufacturing animaging window embodying the invention is shown in FIG. 5. Thecorresponding imaging window assembly fixture 500 is shown in sectionalside view in FIG. 6. An anti-stick coated mandrel 502 includes a mandrel504 and a thin PTFE coating 506. The anti-stick coated mandrel 502 mayhave a diameter in the range 0.0225″ to 0.0340″, generally 0.0330″, andmay be used for loading of a tubing assembly 510. The tubing assembly510 may include a midshaft tubing 512, an imaging window assembly 513,and a distal tubing 520 wherein the imaging window assembly 513 includesan imaging window proximal tubing 514, an imaging window middle tubing516, and an imaging window distal tubing 518. The inner diameter of themidshaft tubing 512, imaging window proximal tubing 514, imaging windowmiddle tubing 516, imaging window distal tubing 518, and soft tip tubing520 may be constant in the range 0.024″ to 0.038″, generally 0.0335″.The wall thickness of the imaging window proximal tubing 514, imagingwindow middle tubing 516, and imaging window distal tubing 516 may be inthe range 0.001″ to 0.007″, generally 0.005″. The midshaft tubing 512may be composed of HDPE having a flexural modulus in the range 200 ksito 250 ksi, generally 225 ksi. The imaging window assembly 513 decreasesin stiffness progressing from proximal to distal direction.

The midshaft tubing 512 is trimmed in step 400 to a length in the rangeof 60 mm to 100 mm, generally 8.0 mm. The trimmed midshaft tubing 512 isloaded onto the PTFE-coated mandrel 502 in step 402. The proximal end ofthe midshaft tubing 512 may be positioned in the range 100 mm to 150 mm,generally 125 mm, from an end of the PTFE-coated mandrel 502. Thedistance from the end of the PTFE-coated mandrel 502 to the proximal endof the midshaft tubing 512 is referred to as the top clamping region508. The length of the top clamping region 508 is sufficiently long toinsure that the vertical laminator clamp does not clamp the midshafttubing 512.

The imaging window proximal tubing 514 is then trimmed in step 404 to alength in the range of 40 mm to 100 mm, generally 70 mm. The trimmedimaging window proximal tubing 514 is loaded onto the PTFE-coatedmandrel 502 in step 406 and positioned next to the midshaft tubing 512.The imaging window proximal tubing 514 may be composed of HDPE having aflexural modulus in the range 195 ksi to 245 ksi, generally 220 ksi.

The imaging window middle tubing 516 is then trimmed in step 408 to alength in the range of 40 mm to 100 mm, generally 50 mm. The trimmedimaging window middle tubing 516 is loaded Onto the PTFE-coated mandrel502 in step 410 and positioned next to the imaging window proximaltubing 514. The imaging window middle tubing 516 may be composed of MDPEhaving a flexural modulus in the range 155 ksi to 205 ksi, generally 180ksi.

The imaging window distal tubing 518 is next trimmed. in step 412 to alength in the range of 10 mm to 50 mm, generally 20 mm. The trimmedimaging window distal tubing 518 is loaded onto the PTFE-coated mandrel502 in step 414 and positioned next to the imaging window middle tubing516. The imaging window distal tubing 518 may be composed of LDPE havinga flexural modulus in the range 35 ksi to 85 ksi, generally 60 ksi.

The distal tubing 520 is next trimmed in step 416 to a length in therange of 10 mm to 30 mm, generally 25 mm. The distal tubing 520 may alsobe composed of PE. The trimmed distal tubing 520 is loaded onto thePTFE-coated mandrel 502 in step 418 and positioned next to the imagingwindow distal tubing 518. The primary purpose of the distal tubing 520is as a processing aid to prevent, shifting the tubing assembly 510position.

The tubing assembly 510 includes the sequence of midshaft tubing 512,imaging window proximal tubing 514, imaging window middle tubing 516,imaging window distal tubing 518, and distal tubing 520. Heat shrinktubing 522 is next loaded over the tubing assembly 510 and the topclamping region 508 of the PTFE-coated mandrel 502 in step 420. The heatshrink tubing 522 may be composed of fluorinated ethylene propylene(FEP). The heat shrink tubing 522 may have an inner diameter in therange 0.042″ to 0.048″, generally 0.045″. The length of the heat shrinktubing 522 is sufficiently long to cover the length of the top clampingregion 508 and the tubing assembly 510 and is at least 380 mm. Any gapsbetween the tubing assembly 510 sections are closed in step 422 bypushing the tubing assembly sections together. This insures that thetubing assembly 510 sections flow together when heated.

The imaging window assembly fixture 500 includes the PTFE-coated mandrel502, the tubing window assembly 510, and the heat, shrink tubing 522.The imaging window assembly fixture 500 is loaded into the verticallaminator in step 424 wherein the top clamping region 508 is fixed inposition by means of a vertical laminator clamp.

The tubing sections of the tubing window assembly 510 are bonded in step426 by means of a vertical laminator heater set to a temperature in therange of 500° F. to 700° F., generally 645° F. The vertical laminatorheater is set sufficiently high to raise the temperature of the imagingwindow assembly fixture such that the tubing window assembly flows, butthe heat shrink tubing does not flow. The transverse speed of a verticallaminator thermal nozzle affects the temperature of the imaging windowassembly fixture and is in the range of 1 mm/s to 10 mm/s, generally 5mm/s.

Following the bonding of the tubing sections, the imaging windowassembly fixture 500 is removed from the vertical laminator in step 428.The heat shrink tubing 522 is removed from the imaging window assembly500 in step 430 by means of a razor or other cutting tool takingparticular care to not cut or abrade the tubing assembly 510. The tubingassembly 510 is then removed from the PTFE-coated mandrel 502 in step432 wherein the tubing assembly includes the midshaft section 512, theimaging window assembly 513, and the soft tip 520.

Referring now to FIG. 7, another embodiment of an imaging windowassembly fixture 600 is shown wherein a tubing assembly 610 includes afirst imaging window assembly 513 and a second imaging window assembly613. A “divider” tubing 612 is loaded between the first imaging windowassembly 513 and second imaging window assembly 613 wherein the dividertubing 612 may be composed of PE, the same material as the midshafttubing 512. The primary purpose of the divider tubing 612 is as aprocessing aid to facilitate segmentation of the first imaging windowassembly 513 and second imaging window assembly 613. The first imagingwindow assembly 513 includes a first imaging window proximal tubing 514,a first imaging window middle tubing 516, and a first imaging windowdistal tubing 518. The second imaging window assembly 613 includes asecond imaging window proximal tubing 614, a second imaging windowmiddle tubing 616, and a second imaging window distal tubing 618. Anadvantage of the alternative embodiment of an imaging window assemblyfixture 600 is more than one imaging window assembly being manufacturedon a PTFE-coated mandrel 502. After processing the imaging windowassembly fixture 600 in a vertical laminator and removing the heatshrink tubing 522, the imaging window assemblies 513, 613 can beseparated by making a roll-cut through the divider tubing 612 by meansof a razor or Other cutting tool. The tubing assembly 610 is thenremoved from the PTFE-coated mandrel 502.

Another embodiment of the tubing assembly may include three or moreimaging window assemblies wherein the imaging window assemblies areseparated by divider tubings. Further, additional imaging windowassembly fixtures can be loaded into a vertical laminator wherein oneimaging window assembly fixture is loaded for each vertical laminatorstation. In still another embodiment of the invention four imagingwindow assembly fixtures may be assembled, wherein each imaging windowassembly fixture includes a tubing assembly having five imaging windowassemblies separated by four divider tubings. A vertical laminatorhaving at least four heating stations may be used to heat bond thetubing assemblies.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedto cover in the appended claims all such changes and modifications whichfall within the true spirit and scope of the invention.

1-18. (canceled)
 19. A method of making an imaging window for use in animaging catheter, the method including the steps of: loading onto amandrel a first imaging window section of a first material having afirst flexural modulus, the first imaging window section having aproximal end, a distal end, a constant outer diameter, and a constantinner diameter; loading onto the mandrel a second imaging window sectionof a second material having a second flexural modulus, the secondimaging window section having a proximal end, a distal end, a constantouter diameter, and a constant inner diameter, wherein the secondflexural modulus is different than the first flexural modulus; andjoining the distal end of the first imaging window section to theproximal end of the second imaging window section such that the firstmaterial of the first imaging window section contacts the secondmaterial of the second imaging window section.
 20. The method of claim19, further comprising the step of applying heat shrink tubing over atleast the distal end of the first imaging window section and theproximal end of the second imaging window section prior to joining thedistal end of the first imaging window section to the proximal end ofthe second imaging window section.
 21. The method of claim 20, whereinjoining the distal end of the first imaging window section to theproximal end of the second imaging window section comprises applyingheat to the distal end of the first imaging window section and theproximal end of the second imaging window section.
 22. The method ofclaim 21, wherein, upon applying heat, the distal end of the firstimaging window section flows together with the proximal end of thesecond imaging window section to preclude any gaps there between thatare not transparent to ultrasound energy.
 23. The method of claim 21,further comprising the steps of: removing the heat shrink tubing afterapplying heat to the distal end of the first imaging window section andthe proximal end of the second imaging window section; and removing theimaging window from the mandrel after applying heat to the distal end ofthe first imaging window section and the proximal end of the secondimaging window section.
 24. The method of claim 19, wherein joining thedistal end of the first imaging window section to the proximal end ofthe second imaging window section comprises bonding the distal end ofthe first imaging window section to the proximal end of the secondimaging window section without the use of adhesive material between thedistal end of the first imaging window section and the proximal end ofthe second imaging window section.
 25. The method of claim 19, whereinthe constant outer diameter of the first imaging window section is equalto the constant outer diameter of the second imaging window section. 26.The method of claim 25, wherein the constant inner diameter of the firstimaging window section is equal to the constant inner diameter of thesecond imaging window section.
 27. The method of claim 19, wherein thefirst material and the second material are transparent to ultrasoundenergy.
 28. The method of claim 27, wherein the joining the distal endof the first imaging window section to the proximal end of the secondimaging window section comprises creating a continuous length from thefirst imaging window section to the second imaging window section thatis transparent to ultrasound energy.
 29. The method of claim 19, whereinthe first material and the second material each have imaging performancecharacteristics, and wherein the imaging performance characteristics ofthe first material and the second material are equivalent.
 30. Themethod of claim 29, wherein the first material and the second materialcomprise polyethylene.
 31. A method of making an imaging window for usein an imaging catheter, the method including the steps of: providing amandrel having an anti-stick coating thereon; successively loading aplurality of imaging window tubing sections onto the mandrel, whereineach of the imaging window tubing sections has a flexural modulusdifferent than a flexural modulus of the other imaging window tubingsections; joining the imaging window tubing sections end-to-end togetherto form an imaging window section; and removing the imaging windowsection from the mandrel.
 32. The method of claim 31, whereinsuccessively loading comprises loading the plurality of imaging windowtubing sections onto the mandrel in a successive order corresponding toprogressive change in the flexural modulus of the imaging tubing windowsections.
 33. The method of claim 32, wherein the successive ordercorresponds to a progressive increase in the flexural modulus of theimaging window tubing sections.
 34. The method of claim 31, wherein theimaging window tubing sections are formed from polyethylene material.35. The method of claim 31, wherein joining the imaging window tubingsections end-to-end together comprises applying heat to the imagingwindow tubing sections.
 36. The method of claim 35, wherein joining theimaging window tubing sections end-to-end together comprises coveringthe imaging window tubing sections with a heat shrink tubing prior toapplying heat to the imaging window tubing sections.
 37. The method ofclaim 35, wherein prior to applying heat to the imaging window tubingsections the imaging window tubing sections are positioned adjacent avertical laminator.
 38. The method of claim 31, wherein the plurality ofimaging window tubing sections forms a first plurality of imaging windowtubing sections comprising the first imaging window section, and whereinthe method further includes: successively loading a second plurality ofimaging window tubing sections onto the mandrel, wherein each of theimaging window tubing sections of the second plurality of imaging windowtubing sections has a flexural modulus different than the flexuralmodulus of the other imaging window tubing sections of the secondplurality of imaging window tubing sections; positioning a spacer tubingon the mandrel between the first plurality of imaging window tubingsections and the second plurality of imaging window tubing sections;joining the first plurality of imaging window tubing sections and thesecond plurality of imaging window tubing sections end-to-end togetherto form first and second imaging window sections, respectively; andremoving the first and second imaging window sections from the mandrel.